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Everolimus and Tacrolimus Combination for Regression of Left Ventricular Hypertrophy in Renal Transplants

NCT ID: NCT03415750

Last Updated: 2021-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-05-31

Brief Summary

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Clinical study with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.

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Detailed Description

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A single-center, randomized, open-label, 12 months study, with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.

Conditions

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Hypertrophy, Left Ventricular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Everolimus arm

Patients will be converted from Tacrolimus + Mycophenolate mofetil to Everolimus + Tacrolimus 'Conversion from Mycophenolate mofetil to Everolimus'

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

Conversion from Mycophenolate mofetil to Everolimus

Tacrolimus

Intervention Type DRUG

Mycophenolate arm

Patients will remain in Tacrolimus + Mycophenolate mofetil combination

Group Type ACTIVE_COMPARATOR

Mycophenolate mofetil

Intervention Type DRUG

Patients will remain in Tacrolimus + Mycophenolate mofetil

Tacrolimus

Intervention Type DRUG

Interventions

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Everolimus

Conversion from Mycophenolate mofetil to Everolimus

Intervention Type DRUG

Mycophenolate mofetil

Patients will remain in Tacrolimus + Mycophenolate mofetil

Intervention Type DRUG

Tacrolimus

Intervention Type DRUG

Other Intervention Names

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Certican Cellcept Prograf

Eligibility Criteria

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Inclusion Criteria

* Patient's signed informed consent prior to any study-related procedure.
* Adult patients (\> 18 years), renal transplant recipients of more than 1 year of evolution.
* Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA.
* Patients with Left Ventricular Hypertrophy detected by Cardio-NMR.
* Subjects with glomerular filtration rate \>30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation \<20%).
* No known contraindications to the use of Mtor inhibitors (previous intolerance, deep vein thrombosis , pulmonary embolism, proteinuria \> 0.5 g/day)
* Patients with Hb levels ≥ 11 gr/dl.
* Patients with blood pressure \<140/90 mmHg in the hospital visits or \<135/85 mmHg at home.

Exclusion Criteria

* Patient's signed informed consent prior to any study-related procedure.
* Adult patients (\> 18 years), renal transplant recipients of more than 1 year of evolution.
* Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA.
* Patients with Left Ventricular Hypertrophy detected by Cardio-NMR.
* Subjects with glomerular filtration rate \>30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation \<20%).
* No known contraindications to the use of Mtor inhibitors (previous intolerance, deep vein thrombosis , pulmonary embolism, proteinuria \> 0.5 g/day)
* Patients with Hb levels ≥ 11 gr/dl.
* Patients with blood pressure \<140/90 mmHg in the hospital visits or \<135/85 mmHg at home.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edoardo Melilli

OTHER

Sponsor Role lead

Responsible Party

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Edoardo Melilli

Principal Investigator MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Edoardo Melilli, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari de Bellvitge

Locations

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Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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ENHVIE

Identifier Type: -

Identifier Source: org_study_id

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